Hypofractionated Radiotherapy With Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer
Single center, single arm, Phase II study designed to evaluate the feasibility of hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with 4D PET/CT-based radiation treatment planning and concurrent carboplatin and paclitaxel in Stage IIIA or Stage IIIB NSCLC subjects.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 5, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Stephanie Smiddy
- Interventions being studied
- Radiation: 2.5 Gy/fraction; Drug: Carboplatin; Drug: Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC).
- Stage IIIA subjects who are considered eligible for resection following neoadjuvant chemoradiation are eligible for this study.
- No PET/CT evidence of metastatic disease.
- An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons.
- If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible.
- Subjects must have measurable or evaluable disease.
- No prior thoracic radiotherapy.
- Age \> 18 years at time of registration.
- ECOG Performance Status of 0-2 (Karnofsky performance scale ≥ 60).
- Hgb \> 9 g/dL; ANC (absolute neutrophil count) \> 1500/µl; platelets \> 100,000 mcL.
- Subjects must sign study-specific informed consent form prior to registration.
- Radiation therapy and chemotherapy must start within 4 weeks of study enrollment.
- Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
- Active connective tissue disorders, such as active lupus or scleroderma.
- Known Acquired Immune Deficiency (HIV (+)/AIDS).
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regiment to harm nursing infants. Women of childbearing potential must agree to use medically approved and adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Toledo, Eleanor N. Dana Cancer CenterToledo, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 5, 2020. Always confirm current availability with the study team.